Fecal incontinence is a condition in which fecal material is involuntarily excreted or leaked due to decreased bowel control. Fecal incontinence of varying degrees is thought to be a result of any number of factors, including dysfunction of or damage to the anal sphincters, dysfunction of the pelvic floor, decreased compliance in the rectum, impaired sensation in the rectum, and fecal impaction. However, a significant number of women develop fecal incontinence after experiencing anal sphincter tears and/or pudendal nerve trauma during vaginal child delivery. Conventional treatments for fecal incontinence include medical therapy (such as diet changes, supplements, or drugs), and biofeedback therapy (in which a patient is taught to retrain the musculature of the pelvic floor and abdominal wall), but these treatments are often supplemental measures that do not fully treat major incontinence.
A common surgical treatment for fecal incontinence is sphincteroplasty involving overlap repair of the external anal sphincter, which is successful for a portion of patients with damage to the sphincter. Other surgical treatments include transplantation of striated muscle to replace irreversibly damaged sphincter muscles, insertion of a synthetic sphincter device controlled by a hand pump, and a colostomy in which the colon is connected to an opening on the abdominal wall to allow feces to pass through the abdomen. However, these treatments have drawbacks. Sphincteroplasty is a technically challenging procedure, and is not suitable for all patients with sphincter damage, such as those with sphincter defects spanning over 180 degrees of the sphincter perimeter. Furthermore, many sphincteroplasties lead to unsatisfactory results, as the procedure typically requires long incisions that are more susceptible to infection and incision break down, and many sphincteroplasties eventually fail after some time. Transplantation of muscle or insertion of a synthetic sphincter device is relatively invasive and time-consuming, and a synthetic sphincter device is an inconvenient, less than ideal solution that has a high complication and explant rate. A colostomy is also less than ideal, since it is a major, life-changing procedure that is typically performed as a last resort when other treatments have failed or are unsuitable.
The stigma associated with fecal incontinence often leads to shame and problems with self-confidence, resulting in social withdrawal and isolation. Successful and appropriate treatments for fecal incontinence are crucial for maintaining quality of life for patients afflicted with the condition. Thus, there is a need to create an improved treatment for fecal incontinence. This invention provides such an improved anal sling system and method to treat fecal incontinence in the surgical field.